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Company Presentation Summer 2004 Medivir in brief • One of the world leaders in polymerase research. • Aiming for a similar position in protease research. • Unique competitive advantages in all clinical projects. • Nine partnerships with eight companies and a broad network with academia in Europe and US. • Total deal value amounting to > SEK 2000m • Nordic marketing rights for all projects. • Located in Stockholm (Sweden) and Cambridge (UK) with approximately 100 employees in R&D. Skilled and experienced management Anders Vedin – M.D., Professor – Chairman of the Board Previous positions include President of Astra Hässle Lars Adlersson – B.Sc. (Business Adm & Econ) – CEO Previous positions include Vice President and General Manager GlaxoSmithKline Austria, Managing Director GlaxoWellcome Sweden. Johan Harmenberg M.D. Associate Professor – VP Drug Development Previous positions include Clinical Research Director, Medical Advisor and Medical Director at Roche, Astra and Pharmacia & Upjohn. Bertil Samuelsson – Ph.D. Professor – VP Research Previous positions include Head of Medical Chemistry at AstraZeneca. Rein Piir – B.Sc. (Business Adm & Finance) – CFO / IR Previous positions include Head of Research and Health Care at Carnegie Investment Banking, Health Care and Strategy at Alecta Asset Management Paul Wallace - Ph.D. – VP Business Development Previous positions include Business Development Manager at Peptide Therapeutics and Director of Research at Eclagen. Medivir pipeline and market Medivir’s clinical and pre-clinical projects Discovery Lead Optimisation Late preclinical identification phase development RP-606 Shingles ME-609 Labial herpes MIV-310 NRTI Multi-resistant HIV MIV-210 NRTI Multi-resistant HIV MIV-150 NNRTI HIV IND Phase I Phase II Phase III NDA Market Population Council MV026048 Cath S Cath K MIV-170 HCV HCV Alzheimer COPD New proteases Other activities Polymerase inhibitor Combination including polymerase inhibitor Protease inhibitor Polymerase and protease inhibitors Unique Selling Propositions in all clinical projects • Valomaciclovir (RP 606) – shingles Expected to reduce chronic pain • ME 609 – labial herpes Expected to prevent ulcerative lesions • Alovudine (MIV 310) - HIV-NRTI Excellent activity against multi-resistant strains Once daily dosing •MIV 210 – HIV-NRTI Excellent activity against multi-resistant strains High oral bioavailability Valomaciclovir (RP 606) Indication: Shingles Competitive advantage: IP protection: Partner: Status: Expected to reduce chronic pain Patents to 2017 Reliant (1.000 sales reps in US) Phase II completed Ongoing preparations for Phase III expected to reduce chronic pain The chronic pain (PHN), is the major problem for shingles patients Share of patients Acute phase Chronic pain time expected to reduce chronic pain ME 609 Indication: Competitive advantages: IP protection: Partner: Status: avoid your next cold sore Labial and genital herpes First drug to prevent labial lesions Patents to 2016 in US and EU No Positive phase II data Preparation prior to phase III ongoing You can avoid your next cold sore No treatment 0% Existing drugs 0% 29% ME 609 Avoided outbreaks avoid your next cold sore 0% 5% 10% 15% 20% 25% 30% Alovudine (MIV 310) Indication: Competitive advantages: IP protection: Partner: Status: HIV No resistance development observed in phase IIa, or in vitro. Unique multi-resistance profile. Once daily oral dosing Exceptionally low COGS Patents to 2019 (USA) Boehringer Ingelheim Phase IIa data showed unique activity against multi-drug resistant HIV Licensed to Boehringer Ingelheim in July 2003 BI recently started phase II dose range studies MIV 210 Indication: Competitive advantages: IP protection: Partner: Status: * Information from GSK’s R&D-day HIV, Hepatitis B Unique multi-resistance profile, different from MIV-310 Excellent oral bioavailability in humans Low COGS Next generations NRTI in fixed-dose-combination* Patents to 2018 GlaxoSmithKline Licensed to GSK in May 2003 Broad range of preparations prior to phase II ongoing NDA expected to be filed in H2 2007 * Expected peak sales: USD 500 – 1.000m * High Market Potential* RP-606 Shingles Sales of shingles drugs > USD 1.000m in 2003. None of the existing drugs have a claim for PHN ME-609 Labial herpes MIV-310 NRTI Multi-resistant HIV Even without any drug preventing labial herpes, sales amounted to more than USD 500m in 2003 MIV-210 NRTI Multi-resistant HIV MIV-150 NNRTI HIV Sales of HIV drugs amounted MV026048 to USD 5.800m in 2003. NRTI’s represented 60% and are MIV-170 expected to grow their Cath S market share above 70% in the Cath K coming five years HCV HCV Alzheimer COPD * Market data according to IMS-data Population Council Growing share of multiresistant HIV. MIV-310 and 210 are developed to address this HIV market is expected to grow rapidly, NRTI’s having the largest share Polymerase Inhibitors, NRTI Combivir (GSK) Zerit (BMS) Epivir (GSK) Trizivir (GSK) Viread (Gilead) * Rest Total 2000 807 620 448 11 0 584 2470 2001 872 546 435 241 13 605 2712 2002 882 443 443 473 226 597 3064 2003 966 354 480 617 566 512 3495 2002 3064 763 1422 5249 2003 3495 930 1411 5836 P2004 4071 1104 1725 6900* * High need of new Multi - resitant profiles USD m Polymerase Inhibitors, NRTI Polymerase Inhibitors, NNRTI Protease Inhibitors, PI Total * According to DataMonitor 2000 2470 680 1700 4850 2001 2712 705 1770 5187 P2010 7808 1952 2440 12200* The Late Stage Preclinical Pipeline Discovery Lead Optimisation Late preclinical identification phase development IND Phase I Phase II Phase III NDA Market MV026048 Cath S A new treatment paradigm for RA, MS and asthma. Possible improvements over TNF-alpha blockers. Cath K MIV-170 HCV HCV COPD Strong presence in hepatitis C New treatment paradigm for osteoporosis and osteoarthritis. Present therapies like, bisphosphonates and HRT all have limitations Polymerase inhibitor Protease inhibitor The Cathepsin S Project (JV with Peptimmune) Potential indications: • Immunological disorders (e.g. rheumatism, multiple sclerosis) • Chronic pain Competitive advantages: • New class of drugs for treating autoimmune and inflammatory diseases. Project status: • Potent and selective compounds identified. • Oral administration results in impressive efficacy in pre-clinical disease models. • EU-patent granted for cathepsin S-inhibitors in immune reactions. • A Candidate Drug was recently selected in the program, and the project is now in preclinical development towards a IND. • No competing projects identified in clinical development Osteoporosis and Cathepsin K Osteoporosis: • The amount of treated patients is expected to grow from 7.8m (2002) to 18.3m (2015)* • Market size 2001: USD 5.5bn (2001) is expected to grow to USD 11bn(2008)** Cathepsin K: • An enzyme involved in the process of bone destruction. • By inhibiting cathepsin K, the bone destruction process is reduced. • This has recently been proved by Novartis in a phase IIa POC study. • No other competing projects identified in clinical development. *Datamonitor, Epidatabase (2003) **IMS Data Medivir’s Cathepsin K Project Potential indications: • Osteoporosis • Osteoarthritis, Paget’s Disease, Bone metastasis, RA, Bone cancer etc. Competitive advantages: • A new treatment principle. By regulating cathepsin K the bone breakdown process will be controlled. This will open up possibilities in a range of diseases. Project status: • Potent and selective inhibitors of cathepsin K with drug like properties identified. • The inhibitors have shown good effect in an in vitro-model for human bone resorption. • The project is at an advanced stage in i preclinical optimisation. • Strong IP on NCE’s have been filed. Balancing risk Five individual projects in clinical development RP-606 Shingles ME-609 Labial herpes MIV-310 NRTI Multi-resistant HIV MIV-210 NRTI Multi-resistant HIV Total deal value MIV-150 NNRTI HIV Population Council > SEK 2.000m MV026048 Cath S Cath K Five individual Three Joint MIV-170 projects able to Ventures HCV generate royalty HCV Four individual projects Alzheimer able to generate COPD milestones New proteases Other activities Partners in four clinical projects The strategic journey Medivir: the strategic journey Today Tomorrow development and protease inhibitors in • Polymerase and protease inhibitors in clinical development pre-clinical research. • Broad range of partnerships. • Polymerase inhibitors in clinical • Broad range of partnerships. • First product launch from own pipeline. • Nordic marketing rights to all projects. • Aim for product swaps in coming • Approximately 120 employees. • Research based biotech company. partnerships. • Research based pharmaceutical company with a sales force focusing on specialist products for the Nordic region. A broader clinical portfolio creates higher value Value Osteoporosis Autoimmune disorders 2004 and onwards Infectious diseases Infectious diseases Time Financial information Key Financial Data 31th of March 2004 • • • • Result after financial items amounted to SEK -45,3 (-47,1)m. SEK 208m in cash. Net R&D costs for 2004 will be approximately SEK 175m, this is in line with previous years. The Q2 report will be published on the 6th of July. World leader in drugs inhibiting proteases and polymerases